Nicotine pouch performance is often discussed almost exclusively in terms of formulation. Nicotine concentration, pH, buffering systems, flavour chemistry, and moisture balance dominate both technical development and regulatory review. These elements are undeniably important. However, emerging evidence and user experience suggest that formulation alone does not fully explain how nicotine pouches are tolerated, used, or abandoned.
Nicotine pouches operate at a physical interface. They are placed under load, against sensitive oral tissue, in a moist environment, and for extended periods of time. In this context, interface geometry, the physical shape and structure of the pouch as it contacts the gum, deserves far greater attention than it currently receives in regulatory and product discussions.
This is not a cosmetic or branding issue. It is a mechanical one, with direct implications for user comfort, consistency of use, and ultimately harm-reduction outcomes.
Lessons From Other Sectors: When Geometry Changed Performance
There is a clear precedent for this line of thinking in other regulated and consumer-safety-critical sectors. A well-documented example comes from athletic footwear design.
Nike’s development of the Nike Free line did not begin with new foam compounds or materials. Instead, designers studied how the human foot behaves when running barefoot. Their findings were consistent: the foot does not land flat, pressure shifts dynamically, and stability comes from motion rather than rigid support. Traditional flat, uniform shoe soles disrupted these mechanics, forcing cushioning materials to absorb forces they were not designed to manage alone.
Nike’s innovation was geometric rather than chemical. By introducing segmented soles, flex grooves, and structures that allowed pressure to move rather than concentrate, they changed how forces were distributed across the foot. Comfort and performance improved not because materials became softer, but because the interface itself behaved differently.
The same principle applies to sustained-contact products in many fields, including seating, medical devices, wearables, and oral-use products.
Pressure, Contact, and Irritation in Nicotine Pouches
User reports of nicotine pouch discomfort are remarkably consistent across markets and product types. Burning, stinging, and soreness are commonly cited, particularly with prolonged use. When irritation increases, behaviour changes. Users reposition pouches, shorten use time, or stop using them entirely.
From a harm-reduction perspective, this matters. Products that are not tolerated consistently are less likely to displace cigarette smoking effectively.
While formulation is often blamed for irritation, the mechanical environment inside the mouth is demanding. Flat or uniform contact surfaces tend to concentrate pressure. Soft materials compress, collapse, and trap moisture and heat. Over time, this leads to localised stress on gum tissue.
Geometry alters this interaction. Structured interfaces can distribute load more evenly, resist full collapse under pressure, stabilise contact over time, and allow moisture and heat to move rather than pool. These changes influence how the same formulation is experienced by the user.
Emerging Evidence That Geometry Affects Outcomes
This is not merely theoretical. A European pilot study, frequently referenced as having been conducted in Switzerland, examined a nicotine pouch incorporating a protective, gum-facing interface. Over several weeks, participants showed measurable reductions in reported irritation and observable mucosal effects.
Crucially, these improvements were not driven by major changes in nicotine chemistry or formulation. They correlated with how the pouch contacted oral tissue. This aligns closely with evidence from other sectors where interface design has been shown to materially affect comfort and tolerability without altering active ingredients.
For regulators and standards bodies, this distinction matters. It suggests that design features can reduce adverse effects without increasing exposure or delivery, an important consideration in proportional regulation.
Why This Matters for Harm Reduction and Regulation
Harm-reduction products only achieve public-health benefit if they are used comfortably and consistently by adults who would otherwise smoke. Interface geometry offers a credible pathway to improve tolerability without increasing nicotine strength, altering toxicological profiles, or introducing new substances.
From a regulatory standpoint, this raises important questions. Current assessment frameworks focus heavily on chemistry and emissions, with limited attention to mechanical interaction with tissue. As nicotine pouches continue to evolve, regulators may need to consider whether product standards adequately capture factors that influence real-world use, comfort, and persistence.
This is not an argument to deprioritise formulation science. Rather, it is a call to recognise that mechanical design and formulation interact, and that overlooking interface geometry may lead to incomplete evaluations of both risk and benefit.
A Credible Next Frontier
For an industry and regulatory ecosystem that has invested heavily in toxicology, exposure science, and population modelling, interface geometry represents an under-explored but scientifically grounded area of innovation. Improvements in this domain could enhance user experience, support sustained switching away from smoking, and do so without undermining regulatory safeguards.
As with all harm-reduction tools, nuance matters. Geometry does not eliminate risk, nor does it replace robust product oversight. But evidence suggests it can meaningfully influence outcomes, and that alone makes it worthy of serious regulatory and scientific attention.
Author:
Michael Fruhling
Founder & CEO, BFS Innovations, Inc.
📧 michael@bfsinnovations.com







